Wednesday, January 13, 2010

Ron Sato joined us this morning to whip through a rather cerebral yet informative talk about the FDA drug approval process, giving numerous historical examples of how scandals, abuses, mistakes, led to the passage of more stringent laws, bringing us to where we are today.

Ron did post-doctoral work at Rochester & Brown before joining American/DuPont-Merck. He participated in programs which generated Losartan, the first ARB (angiotensinogen receptor blocker) to reach the market, and Esmolol (a niche beta blocker).

The ensuing conversation focused on the bioethics around clinical trials, and ways desperate individuals sometimes attempt to work around the FDA, such as by getting their medicines less expensively from Canada.

The AIDS/HIV epidemic generated enough political pressure to expedite (fast track) the approval of some drugs. Many past scandals have involved drugs getting to the public without sufficient testing. Ron had several examples, including the 1937 Sulfanilamide Disaster, well documented by Carol Ballentine at the FDA website.

The ongoing illegality of marijuana and the consequent drug war in Mexico was also a topic of conversation. We did not talk about cocaine or the opiates, and the drug wars around those, in Columbia and Afghanistan respectively.

Several of those present bemoaned what they perceived as a loss of productive public debate in this country, given how shrill polemics and punditry have seemingly taken over on television. Where is our ability to collectively process information? How will our civilization advance? Through Youtube?

My position was that affordable health care, education etc., all need to go on the back burner so long as the priority is military spending. We just can't have it both ways. We're facing some either/or choices. This was not a new or original idea, just plain common sense. As a planet, our living standards are on hold, or are slated to go down, to the extent human beings focus on destroying their own infrastructure. That's really just a truism, disguised as an empirical fact.

Patrick and I had a similar conversation recently, wherein I regurgitated some of my National Geographic reading. If we ate less meat, had a healthier diet, and focused more on global electrification as an ongoing top priority, we might yet improve living standards. Kilowatts per capita consumption is inversely proportional to population growth, is thinking here. We're looking for those "gentle checks" Malthus was hoping we'd find.

However, I'm getting somewhat off topic here. More to the point were the zebra fish, which Ron knew quite a bit about. They're used by ONAMI companies, as I recalled. You want genetically simple creatures for early clinical trials. Testing on blow fish was another option, but zebra fish, being transparent, proved to have more potential.

Ron will be giving a similar talk at Reed College in a few days. We were fortunate to learn from his experience.